CTRI/2023/02/049494尚未招募2 期
Adjuvant chemotherapy for operated amPullary AdenoCarcinomas based on Histology and Intensification- A two arm non-randomized open label prospective parallel adaptive design phase II clinical trial. - APACHI
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •No radiological evidence of metastatic disease or/and metastatic disease as discovered by on table evaluation during definitive surgery for GBC peritoneal disease, liver metastases etc.
- •-Histologically confirmed adenocarcinoma of the ampulla post resection with the following specifications.
- •-Anatomically
- •Growth in the lumen or walls of the distal ends intra ampullary component of the common bile duct. (CBD) and or pancreatic duct,
- •-Growth of the papilla of Vater, or
- •Growth at the duodenal surface on the papilla (the duodenal facing surface of the ampullary protuberance) with the ampullary orifice clearly located with in the lesion.
- •-Stage as per AJCC 8th edition
- •-R0/R1 resection
- •-ECOG performance status 0-1
- •-Patient who give informed consent for the study.
- •-Patient does not have any contraindication to receive Chemotherapy.
- •-Duration between surgery and fitness for randomization to adjuvant therapy more than or equal to 90 days.
- •-Adequate hematological, hepatic and renal function parameters.
- •Hematological- HB more than 80 g/L, ANC more than equal to 1.5 x 109/L, platelets more than 100 x 109/L, liver function bilirubin less than of equal to 2 x upper limit normal (ULN), AST ALT less than equal to 5 x ULN, S. albumin more than equal to 30 g/L, Renal function Creatinine less than equal t 1.5 ULN, Creatinine clearance more than equal to 50 ml/ min.
- •-Normal cardiac function, as assessed by echocardiography and ECG.
- •-Women of childbearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment face of the trial.
- •-Written Patient consent form.
排除标准
- •-Resected Pancreatic cancers or resected patients with doubtful epicenter of primary.
- •-R2 resections
- •-Known hypersensitivity or contraindications against capecitabine, 5 FU, Irinotecan, or Oxaliplatin.
- •-Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV,
- •-Clinically significant valvular defect.
- •-Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix.
- •-Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy, NYHA/ATS G2 and above
- •-Other severe internal disease or acute infection
- •-Baseline neuropathy > NCI Grade I
- •-Chronic inflammatory bowel disease
- •-On-treatment participation in another clinical study in the period 30 days prior to inclusion and during the study.
- •-Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
研究者
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